PCVX Vaxcyte Inc.

19.14
-0.1  -1%
Previous Close 19.24
Open 19.09
52 Week Low 15.51
52 Week High 58.475
Market Cap $983,388,892
Shares 51,378,730
Float 34,354,448
Enterprise Value $668,535,765
Volume 145,430
Av. Daily Volume 364,481
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VAX-24
Pneumococcal conjugate vaccine
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  1. FOSTER CITY, Calif., May 11, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced financial results for the first quarter ended March 31, 2021 and provided a business update.

    "Over the past few months, we have made good progress as we advance VAX-24, our 24-valent pneumococcal conjugate vaccine (PCV), toward the anticipated submission of the Investigational New Drug (IND) application in order to generate clinical proof-of-concept data," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. "While we remain…

    FOSTER CITY, Calif., May 11, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced financial results for the first quarter ended March 31, 2021 and provided a business update.

    "Over the past few months, we have made good progress as we advance VAX-24, our 24-valent pneumococcal conjugate vaccine (PCV), toward the anticipated submission of the Investigational New Drug (IND) application in order to generate clinical proof-of-concept data," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. "While we remain laser-focused on delivering on our VAX-24 milestones, I am also very excited by the progress made to advance our pipeline vaccines, including VAX-XP, our PCV candidate with an expanded breadth of coverage, and VAX-A1, our novel conjugate vaccine designed to provide universal protection from Group A Strep infections."

    Recent Highlights

    • Advanced VAX-24 IND-Enabling Activities: Vaxcyte continues to progress several initiatives for VAX-24 in connection with its anticipated IND application submission to the U.S. Food and Drug Administration (FDA) and ensuing Phase 1/2 clinical proof-of-concept study initiation. Among other activities, the Company made substantive progress toward completion of the final stage of production of the 24 good manufacturing practice (GMP) conjugated drug substances.



    • Published New Research Supporting VAX-24 and Vaxcyte's Technology Platform: Since the beginning of 2021, Vaxcyte published preclinical VAX-24 data as well as research supporting its technology platform. The papers can be accessed here: https://vaxcyte.com/posters-publications/.   



      • The paper, "Non-clinical Immunological Comparison of a Next-Generation 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) Using Site-Specific Carrier Protein Conjugation to the Current Standard of Care (PCV13 and PPV23)," published in the journal Vaccine, uses a rabbit model to evaluate the immune response of Vaxcyte's 24-valent PCV candidate compared to Prevnar13® (PCV13) and Pneumovax®23 (PPV23). In this study, all serotype conjugates (pneumococcal strains) in VAX-24 met the primary objective to elicit immune responses that were more robust compared to PPV23 and at least comparable to PCV13.
      • The paper, "Sitespecific antigenadjuvant conjugation using cellfree protein synthesis enhances antigen presentation and CD8+ Tcell response," was published in the journal Scientific Reports, and demonstrated an enhanced CD8 positive T-cell response by directly conjugating an adjuvant to a candidate antigen. This expansion of Vaxcyte's site-specific technology platform has potential application in viral vaccines where an enhanced CD8 T-cell response is required.



    • Appointed Janet Graesser, Vice President, Corporate Communications and Investor Relations: In April 2021, Vaxcyte appointed Janet Graesser as Vice President of Corporate Communications and Investor Relations. Mrs. Graesser brings to Vaxcyte over 20 years of healthcare communications experience and expertise across a variety of areas, including corporate communications and strategy, public relations and organizational communications. She dedicated 13 years of her career working at leading healthcare communications firms, ultimately serving as an Executive Vice President, delivering communications strategy and implementation to biotech, pharmaceutical and consumer health companies, including Amgen, GlaxoSmithKline (GSK), Johnson & Johnson (J&J), Pfizer and Merck. She went on to hold an operating role at J&J with responsibility for internal and external communications across seven J&J medical device companies, including Cordis. Mrs. Graesser remained in a senior leadership role with Cordis when it was acquired by Cardinal Health, ultimately serving as the Vice President of Global Communications and Strategy Implementation. Mrs. Graesser went on to establish her own consulting practice that successfully supported both large and small biotech companies.

    "I would also like to acknowledge the key role that Bill Newell, the Chief Executive Officer of Sutro Biopharma who will be stepping down from the board at the end of his term in June, has played in the creation of Vaxcyte," said Mr. Pickering. "We are grateful for Bill's quality stewardship as a director and his recognition that the cell-free protein synthesis platform could be more broadly applied, which was an instrumental catalyst in starting Vaxcyte."

    Anticipated Key Milestones

    Vaxcyte reaffirmed its previously issued guidance for its pipeline programs.

    • VAX-24: Vaxcyte expects to submit an IND application for VAX-24 to the FDA between January and June 2022. Vaxcyte expects to announce topline data from the ensuing Phase 1/2 clinical proof-of-concept study between late 2022 and early 2023.



    • VAX-A1: Following the nomination of its final vaccine candidate for VAX-A1 in the first quarter of 2021, Vaxcyte plans to initiate IND-enabling studies in the second half of 2021.



    • VAX-PG: Vaxcyte expects to nominate a final vaccine candidate for VAX-PG, its novel therapeutic vaccine designed to treat periodontal disease, in the second half of 2021.

    First Quarter 2021 Financial Results

    • Cash Position: Cash, cash equivalents and investments were $370.9 million as of March 31, 2021, compared to $386.2 million as of December 31, 2020.



    • Research & Development (R&D) Expenses: R&D expenses were $17.3 million for the three months ended March 31, 2021 as compared to $24.3 million for the same period in 2020. The decrease was due primarily to a decrease in manufacturing expenses and outsourced research services related to Vaxcyte's VAX-24 program as a result of the completion of the eCRM™ and polysaccharide GMP campaigns in 2020, partially offset by increases in VAX-24 drug substance and drug product activities and VAX-XP activities.



    • General & Administrative (G&A) Expenses: G&A expenses were $5.9 million for the three months ended March 31, 2021 as compared to $3.3 million for the same period in 2020. The increase was due primarily to an increase in personnel-related and directors and officers liability insurance expenses.



    • Net Loss: Net loss was $21.2 million for the three months ended March 31, 2021 as compared to $27.1 million for the same period in 2020.

    About Vaxcyte

    Vaxcyte is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. The Company's cell-free protein synthesis platform, comprising the XpressCF™ platform, exclusively licensed from Sutro Biopharma, Inc., together with Vaxcyte's proprietary know-how, enables the design and production of protein carriers and antigens, the critical building blocks of vaccines, in ways that the Company believes conventional vaccine technologies currently cannot. Vaxcyte's lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Vaxcyte's pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. For more information, visit www.vaxcyte.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements are based on Vaxcyte's current beliefs and expectations. Such statements include, but are not limited to, statements related to: the preventative benefit of Vaxcyte's vaccine candidates; the process and timing of anticipated future development of Vaxcyte's vaccine candidates, including the timing and submission of an IND application for VAX-24 and the initiation of the VAX-24 Phase 1/2 clinical proof-of-concept study thereafter; the timing and availability of topline data for VAX-24; the initiation of IND-enabling activities for VAX-A1; the nomination of a final vaccine candidate for VAX-PG; and other statements that are not historical fact. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte's current expectations, and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte's product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities; Vaxcyte's reliance on third-party manufacturers; potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; sufficiency of cash and other funding to support Vaxcyte's development programs and other operating expenses; and the ongoing COVID-19 pandemic, which could materially and adversely affect Vaxcyte's business and operations. These and other risks are described more fully in Vaxcyte's filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on May 11, 2021 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.

    Contacts:

    Andrew Guggenhime, President and Chief Financial Officer

    Vaxcyte, Inc.

    650-837-0111

    Janet Graesser, Vice President, Corporate Communications and Investor Relations

    Vaxcyte, Inc.

    917-685-8799

    Vaxcyte, Inc. 
    Condensed Statements of Operations 
    (in thousands, except share and per share amounts) 
         
     Three Months Ended 
     March 31, 
     2021

     2020

     
    Operating expenses:    
    Research and development (1)$17,258  $24,315  
    General and administrative (1) 5,885   3,281  
    Total operating expenses 23,143   27,596  
         
    Loss from operations (23,143)  (27,596) 
    Other income (expense), net    
    Interest expense    (7) 
    Interest income 61   135  
    Grant income    329  
    Foreign currency transaction gains (losses) 1,862   (3) 
    Total other income (expense), net 1,923   454  
         
    Net loss$(21,220) $(27,142) 
         
    Net loss per share, basic and diluted$(0.41) $(6.70) 
         
    Weighted-average shares outstanding, basic and diluted 51,174,978   4,049,848  
         
         
    (1) Amounts include stock-based compensation expense as follows:        
         
    Research and development$683  $149  
    General and administrative 1,182   223  
    Total stock-based compensation expense$1,865  $372  
         
    Vaxcyte, Inc. 
    Summary Balance Sheet Data 
    (in thousands) 
         
     March 31, December 31, 
     2021

     2020

     
    Cash, cash equivalents and investments$370,873  $386,200  
    Total assets 382,351   392,826  
    Total stockholders' equity 326,937   345,843  


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  2. FOSTER CITY, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced the publication of preclinical data supporting the potential of VAX-24, its lead vaccine candidate, in the journal Vaccine. VAX-24 is an investigational 24-valent pneumococcal conjugate vaccine (PCV) designed to prevent invasive pneumococcal disease, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions.

    Today, despite widespread PCV vaccination in infants…

    FOSTER CITY, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced the publication of preclinical data supporting the potential of VAX-24, its lead vaccine candidate, in the journal Vaccine. VAX-24 is an investigational 24-valent pneumococcal conjugate vaccine (PCV) designed to prevent invasive pneumococcal disease, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions.

    Today, despite widespread PCV vaccination in infants and older adults, there continues to be considerable impact from disease-causing pneumococcal serotypes, or strains, not covered by the currently available 13-valent PCV. This is largely due to the inherent genetic diversity of Streptococcus pneumoniae, and is further exacerbated by the phenomenon of serotype replacement. High rates of morbidity and mortality due to pneumococcal disease underscore the need for a more broad-spectrum vaccine.

    The paper, "Non-clinical Immunological Comparison of a Next-Generation 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) Using Site-Specific Carrier Protein Conjugation to the Current Standard of Care (PCV13 and PPV23)," which includes previously disclosed data, uses a rabbit model to evaluate the immune response of Vaxcyte's 24-valent PCV candidate compared to Prevnar13® (PCV13) and Pneumovax®23 (PPV23). In this study, all serotype conjugates in VAX-24 met the primary objective to elicit immune responses that were more robust compared to PPV23 and at least comparable to PCV13.

    "Despite widespread, global use of pneumococcal conjugate vaccines, the prevalence of invasive pneumococcal disease remains high, and there is a significant unmet need for a vaccine that provides safe, effective and broader protection," said Jim Wassil, Chief Operating Officer, Vaxcyte. "These preclinical data add to the growing body of evidence supporting the potential for VAX-24, using Vaxcyte's proprietary cell-free protein synthesis platform, to become the broadest-spectrum PCV. We continue to advance VAX-24 in preparation for the anticipated submission of the Investigational New Drug Application to the U.S. Food and Drug Administration in order to generate clinical proof of concept in a Phase 1/2 study."

    Highlights of Study Design and Findings:

    • In this study, VAX-24, PCV13 and PPV23 were administered to New Zealand White rabbits to compare the resulting opsonophagocytic, or neutralizing antibody, activity (OPA) and anti-capsular IgG antibodies generated that specifically bind to all the individual serotypes included in each respective vaccine.
    • The rabbits were dosed at either 0.11µg or 1.1µg of VAX-24 at the start of the study and a booster was given 21 days later. Immunogenicity was measured 14 days after both the initial and booster doses and compared to the 13 serotypes contained in PCV13 and the incremental 11 serotypes contained in PPV23.
    • In the study, VAX-24 showed conjugate-like immune responses to all 24 serotypes based on comparable OPA and IgG responses to PCV13 and higher responses than PPV23.
    • This study demonstrated the utility of Vaxcyte's site-specific conjugation technology in a preclinical setting and the potential for a PCV with broader serotype coverage.

    Vaccine Paper Details and Access

    "Non-clinical Immunological Comparison of a Next-Generation 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) Using Site-Specific Carrier Protein Conjugation to the Current Standard of Care (PCV13 and PPV23)," by Jeff Fairman, Paresh Agarwal, Sandrine Barbanel, Christopher Behrens, Aym Berges, John Burky, Peter Davey, Phil Fernsten, Chris Grainger, Sherry Guo, Sam Iki, Mark Iverson, Martin Kane, Neeraj Kapoor, Olivier Marcq, Thi-Sau Migone, Paul Sauer, and James Wassil. DOI: 10.1016/j.vaccine.2021.03.070. The paper is in press in Vaccine, Vol. 39, issue 23 (2021) published by Elsevier. The paper is available online: https://www.sciencedirect.com/science/article/pii/S0264410X21003741.  

    About Pneumococcal Disease

    Pneumococcal disease is an infection caused by Streptococcus pneumoniae bacteria. This infection can lead to a wide range of serious invasive infections including pneumonia, meningitis and blood stream infections, as well as less severe, non-invasive ear and sinus infections, and can also cause secondary infections due to other respiratory pathogens. In the U.S. alone, approximately 900,000 people get pneumococcal pneumonia each year, including as many as 400,000 requiring hospitalization and approximately 28,000 deaths. Antibiotics are used to treat pneumococcal disease, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to pneumococcal disease are highly significant, particularly for young children and older adults, which underscores the need for a more broad-spectrum vaccine.

    About VAX-24

    VAX-24 is designed to improve upon the standard-of-care PCV vaccine by covering the additional strains that are responsible for the majority of residual pneumococcal disease currently in circulation. Vaxcyte's cell-free protein synthesis platform, which is comprised of the XpressCFTM platform exclusively licensed from Sutro Biopharma, and its proprietary know-how, offer several advantages over conventional cell-based protein expression methods, which Vaxcyte believes enables it to generate a more broad-spectrum PCV. Vaxcyte's approach is focused on expanding coverage by adding more antigenic strains without compromising the overall immune response. Vaxcyte achieved preclinical proof of concept for VAX-24 by demonstrating that VAX-24 has the potential to protect against the pneumococcal strains collectively covered by PCV13 and PPV23 and showed the durable, boostable immune response of a conjugate vaccine. The incremental 11 strains covered by VAX-24 and not covered by PCV13 are responsible for the majority of circulating invasive pneumococcal disease in both the United States and European Union and are associated with high case-fatality rates, antibiotic resistance and/or serious invasive infections.

    About Vaccine

    Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It is the official journal of The Edward Jenner Society and The Japanese Society for Vaccinology and is published by Elsevier www.elsevier.com/locate/vaccine.

    About Vaxcyte

    Vaxcyte is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. The Company's cell-free protein synthesis platform, comprising the XpressCFTM platform, exclusively licensed from Sutro Biopharma, Inc., together with Vaxcyte's proprietary know-how, enables the design and production of protein carriers and antigens, the critical building blocks of vaccines, in ways that the Company believes conventional vaccine technologies currently cannot. Vaxcyte's lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Vaxcyte's pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. For more information, visit www.vaxcyte.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the preventative benefit of VAX-24; the attributes or advantages of the XpressCFTM platform; Vaxcyte's business opportunities; the process and timing of anticipated future development of Vaxcyte's vaccine candidates; whether preclinical data support further development of VAX-24; and the potential success of the VAX-24 program. The words "believe," "could," "expect," "may," "potential," "should," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte's current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte's product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte's development programs and other operating expenses. These and other risks are described more fully in Vaxcyte's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed with the SEC on March 29, 2021 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.

    Contacts:

    Andrew Guggenhime, President and Chief Financial Officer

    Vaxcyte, Inc.

    650-837-0111

    Janet Graesser, Vice President, Corporate Communications and Investor Relations

    Vaxcyte, Inc.

    917-685-8799

     



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  3. FOSTER CITY, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced that Company management will present at the BofA Securities 2021 Health Care Conference on Thursday, May 13, 2021 at 3:30pm ET.

    A live webcast of the presentation can be accessed through the Investors & Media section of the Company's website at http://investors.vaxcyte.com. A replay of the webcast will be available for approximately 30 days following the conference.

    About Vaxcyte
    Vaxcyte is a next-generation vaccine company seeking to improve…

    FOSTER CITY, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced that Company management will present at the BofA Securities 2021 Health Care Conference on Thursday, May 13, 2021 at 3:30pm ET.

    A live webcast of the presentation can be accessed through the Investors & Media section of the Company's website at http://investors.vaxcyte.com. A replay of the webcast will be available for approximately 30 days following the conference.

    About Vaxcyte

    Vaxcyte is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. The Company's cell-free protein synthesis platform, comprising the XpressCFTM platform, exclusively licensed from Sutro Biopharma, Inc., together with Vaxcyte's proprietary know-how, enables the design and production of protein carriers and antigens, the critical building blocks of vaccines, in ways that the Company believes conventional vaccine technologies currently cannot. Vaxcyte's lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). Vaxcyte's pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. For more information, visit www.vaxcyte.com.

    Contacts:

    Andrew Guggenhime, President and Chief Financial Officer

    Vaxcyte, Inc.

    650-837-0111

    Janet Graesser, Vice President, Corporate Communications and Investor Relations

    Vaxcyte, Inc.

    917-685-8799



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  4. FOSTER CITY, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced that company management will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Monday, April 12, 2021 at 1:30 p.m. ET.

    A live webcast of the fireside chat can be accessed through the Investors & Media section of the Company's website at http://investors.vaxcyte.com. A replay of the webcast will be available for approximately 30 days following the conference.

    About Vaxcyte
    Vaxcyte is a next-generation…

    FOSTER CITY, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced that company management will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Monday, April 12, 2021 at 1:30 p.m. ET.

    A live webcast of the fireside chat can be accessed through the Investors & Media section of the Company's website at http://investors.vaxcyte.com. A replay of the webcast will be available for approximately 30 days following the conference.

    About Vaxcyte

    Vaxcyte is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. The Company's cell-free protein synthesis platform, comprising the XpressCF platform, exclusively licensed from Sutro Biopharma, Inc., together with Vaxcyte's proprietary know-how, enables the design and production of protein carriers and antigens, the critical building blocks of vaccines, in ways that the Company believes conventional vaccine technologies currently cannot. Vaxcyte's lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). Vaxcyte's pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. For more information, visit www.vaxcyte.com.

    Contact:

    Andrew Guggenhime, President and Chief Financial Officer

    Vaxcyte, Inc.

    650-837-0111



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  5. FOSTER CITY, Calif., March 29, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced financial results for the fourth quarter and full year ended December 31, 2020 and provided a business update.

    "The past year has been transformational for Vaxcyte and I am pleased with the multiple milestones we have achieved on the path to submit our Investigational New Drug (IND) application for VAX-24, our 24-valent pneumococcal conjugate vaccine (PCV), the progress of our other pipeline programs, and the addition of new leadership team…

    FOSTER CITY, Calif., March 29, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced financial results for the fourth quarter and full year ended December 31, 2020 and provided a business update.

    "The past year has been transformational for Vaxcyte and I am pleased with the multiple milestones we have achieved on the path to submit our Investigational New Drug (IND) application for VAX-24, our 24-valent pneumococcal conjugate vaccine (PCV), the progress of our other pipeline programs, and the addition of new leadership team members," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. "While our team has completed several additional key steps to support the IND application submission for VAX-24, in light of the combination of ongoing work to manufacture the 24 conjugated drug substances, capacity constraints at our contract manufacturing organization and, to a lesser degree, the impact of the COVID-19 pandemic, we are changing the expected timing of our VAX-24 IND application submission to between January and June 2022."

    Pickering continued, "As further confirmation of the progress of our pipeline vaccines and the potential benefits of our technology platform, we are today announcing new immunogenicity data for VAX-XP, our PCV candidate with an expanded breadth of coverage, and the final vaccine candidate nomination for VAX-A1."

    Key 2020 and 2021 Highlights to Date

    • Achieved VAX-24 Manufacturing Milestones: Vaxcyte achieved several key manufacturing milestones for VAX-24 in preparation for the anticipated IND application submission and Phase 1/2 clinical study initiation. These include completion of: the good manufacturing practice (GMP) batches of the eCRM® protein carrier; the GMP batches of the 24 pneumococcal polysaccharides; the first two stages of the GMP batches for the 24 conjugated drug substances; the drug product batches used in the good laboratory practice (GLP) toxicology studies; and the drug product batches that will serve as the source of the lead lot stability data for the IND application.



    • Progressed and Reported New Data for VAX-XP Program: As part of its strategy to maximize the optionality and value of its PCV franchise, Vaxcyte has continued to advance VAX-XP, its broader-spectrum PCV candidate designed to cover at least 30 strains. Today, Vaxcyte announced new data for VAX-XP that further demonstrate the potential benefits of Vaxcyte's scalable technology platform and the reproducibility of data with conjugates produced at larger scale. Results from a preclinical proof-of-concept study showed that in rabbit models for VAX-XP compared to more than 30 different pneumococcal serotypes, including all of those contained in Prevnar 13, the VAX-XP IgG immune responses were superior to polysaccharide-only serotypes and comparable to Prevnar 13 in the common 13 strains.



    • Advanced and Published Data for VAX-A1 Program: Vaxcyte advanced VAX-A1, its novel conjugate vaccine candidate designed to prevent infections from Group A Strep, a human pathogen causing pharyngitis, or strep throat, and certain severe invasive infections such as sepsis, toxic shock syndrome and necrotizing fasciitis. Based on the progress of the program, and consistent with target timelines, Vaxcyte nominated the final VAX-A1 vaccine candidate in the first quarter of 2021. In January 2021, Vaxcyte announced the publication of preclinical data in the journal Infectious Microbes & Diseases, which showed that VAX-A1 demonstrated meaningful protection against systemic and soft tissue infection after challenge with no evidence of cross-reactivity with human tissue. Additionally, at the end of 2020, Vaxcyte completed the initial funding period under its Cooperative Agreement with CARB-X and is now in the process of submitting its proposal to CARB-X for the next funding period of the agreement.



    • Completed Initial Public Offering (IPO) and Series D Financing: In June 2020, Vaxcyte completed its IPO of 17,968,750 shares of common stock, which included the full exercise of the underwriters' option to purchase 2,343,750 additional shares, at a public offering price of $16.00 per share, resulting in aggregate net proceeds of $264.0 million. In March 2020, Vaxcyte completed its Series D convertible preferred stock financing, raising aggregate net proceeds of $109.9 million.



    • Strengthened Leadership Team and Advisory Board with Key Appointments: During 2020, Vaxcyte added several key leaders, including Andrew Guggenhime, President and Chief Financial Officer, and appointed Halley Gilbert to its board of directors, each bringing over 20 years of biotechnology leadership experience. In 2021, Vaxcyte added William Hausdorff, PhD to its Scientific Advisory Board. Dr. Hausdorff has worked on the development, clinical evaluation, registration, implementation and post-marketing assessment of a variety of vaccines over the past 30 years. Since 2018, Dr. Hausdorff has served as the Lead, Public Health Value Propositions for Vaccines at PATH, a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world's most pressing health challenges. Prior to joining PATH, he worked for 12 years at GlaxoSmithKline (GSK) Vaccines, eight years at Wyeth Vaccines and was previously at the Centers for Disease Control and Prevention. In his roles at GSK Vaccines and Wyeth Vaccines, he was involved in the development of Synflorix® and Prevnar 13®, respectively. Dr. Hausdorff received his PhD in Biology from The Johns Hopkins University and his BA in Biology from Carleton College.

    Anticipated Key Milestones

    • VAX-24: Vaxcyte expects to submit an IND application for VAX-24 to the U.S. Food and Drug Administration between January and June 2022. Vaxcyte expects to announce topline data from the ensuing Phase 1/2 clinical study between late 2022 and early 2023.

    • VAX-A1: Following the nomination of its final vaccine candidate for VAX-A1 in the first quarter of 2021, Vaxcyte plans to initiate IND-enabling studies in the second half of 2021.

    • VAX-PG: Vaxcyte expects to nominate a final vaccine candidate for VAX-PG, its novel therapeutic vaccine designed to treat periodontal disease, in the second half of 2021.

    Fourth Quarter and Full Year 2020 Financial Results

    • Cash Position: Cash and cash equivalents were $386.2 million as of December 31, 2020, compared to $59.0 million as of December 31, 2019, an increase due to Vaxcyte's IPO in June 2020 and Series D financing in March 2020, which generated net proceeds of $264.0 million and $109.9 million, respectively.

    • Research & Development (R&D) Expenses: R&D expenses were $14.7 million for the three months ended December 31, 2020 and $73.6 million for the full year 2020 as compared to $13.4 million and $45.6 million, respectively, for the same periods in 2019. The increase for the year ended December 31, 2020 was due primarily to an increase in manufacturing expenses and outsourced research services related to Vaxcyte's VAX-24 program.

    • General & Administrative (G&A) Expenses: G&A expenses were $4.8 million for the three months ended December 31, 2020 and $16.0 million for the full year 2020 as compared to $2.5 million and $8.5 million, respectively, for the same periods in 2019. The increase for the year ended December 31, 2020 was due primarily to an increase in personnel-related and directors and officers insurance expenses.

    • Net Loss: For the three months and year ended December 31, 2020, net loss was $20.7 million and $89.2 million, respectively, compared to $14.6 million and $50.3 million for the same periods in 2019.

    Conference Call and Webcast

    Vaxcyte will host a conference call and webcast to discuss this announcement today, March 29, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. To participate in the conference call, please dial (833) 519-1403 (domestic) or (270) 215-9736 (international) and refer to conference ID 1497487. A live audio webcast will be available in the Investors & Media section of the Company's website at www.vaxcyte.com. A replay of the webcast will be available for 30 days following the call.

    About Vaxcyte

    Vaxcyte is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. The Company's cell-free protein synthesis platform, comprising the XpressCFTM platform, exclusively licensed from Sutro Biopharma, Inc., together with Vaxcyte's proprietary know-how, enables the design and production of protein carriers and antigens, the critical building blocks of vaccines, in ways that the Company believes conventional vaccine technologies currently cannot. Vaxcyte's lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Vaxcyte's pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. For more information, visit www.vaxcyte.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements are based on Vaxcyte's current beliefs and expectations. Such statements include, but are not limited to, statements related to: the preventative benefit of Vaxcyte's vaccine candidates; the process and timing of anticipated future development of Vaxcyte's vaccine candidates, including the timing and submission of an IND application for VAX-24; the timing and availability of topline data for VAX-24; the initiation of IND-enabling activities for VAX-A1; the nomination of a final vaccine candidate for VAX-PG; and other statements that are not historical fact. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte's current expectations, and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte's product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities; Vaxcyte's reliance on third-party manufacturers; potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; sufficiency of cash and other funding to support Vaxcyte's development programs and other operating expenses; and the ongoing COVID-19 pandemic, which could materially and adversely affect Vaxcyte's business and operations. These and other risks are described more fully in Vaxcyte's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed with the SEC on March 29, 2021 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.

    Investor Contact:

    Andrew Guggenhime, President and Chief Financial Officer

    Vaxcyte, Inc.

    650-837-0111

     

    Vaxcyte, Inc.

    Condensed Statements of Operations

    (in thousands, except share and per share amounts)

              

       

     
       Three Months Ended

      Year Ended

     
       December 31,

      December 31,

     
       2020  2019  2020  2019 
     Operating expenses:            
     Research and development (1) $               14,661  $               13,381  $               73,564  $               45,607 
     General and administrative (1)                    4,792                     2,456                   16,017                     8,546 
     Total operating expenses                  19,453                   15,837                   89,581                   54,153 
                  
     Loss from operations                 (19,453)                 (15,837)                 (89,581)                 (54,153)
     Other income (expense), net            
     Interest expense                         —                          (7)                         (7)                       (40)
     Interest income                         32                          94                        244                        632 
     Grant income                       326                        184                     2,478                        237 
     Foreign currency transaction losses                   (1,642)                       280                    (2,351)                     (135)
     Change in fair value of the redeemable convertible preferred stock tranche liability                         —                        665                          —                     3,185 
                  
     Total other income (expense), net                   (1,284)                    1,216                        364                     3,879 
                  
     Net loss and comprehensive loss $              (20,737) $              (14,621) $              (89,217) $              (50,274)
                  
     Net loss per share, basic and diluted $                  (0.41) $                  (3.69) $                  (3.02) $                (13.25)
                  
     Weighted-average shares outstanding, basic and diluted            50,964,294               3,965,166             29,545,810               3,795,090 
                  
                  
     (1) Amounts include stock-based compensation expense as follows:        
                  
     Research and development $                    779  $                    106  $                 1,861  $                    368 
     General and administrative                    1,155                        269                     3,573                        817 
     Total stock-based compensation expense $                 1,934  $                    375  $                 5,434  $                 1,185 
                  
                  



    Vaxcyte, Inc.
    Summary Balance Sheet Data
    (in thousands)
         
      December 31, December 31,
      2020 2019
    Cash and cash equivalents $386,200 $58,976 
    Total assets 392,826  65,698 
    Redeemable convertible preferred stock   160,310 
    Total stockholders' equity (deficit) 345,843  (106,373)
         
         


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